Whitepaper

Successful plant level CAPA deployment

CAPA – or Corrective and Preventive Actions is a widely used business concept across all industries. It is a central concept of ISO standards and good manufacturing practices. The CAPA process essentially describe a set of steps undertaken to improve work processes and minimize risk as well as mitigating the occurrence and recurrence of non-conformances. It can drive dramatic improvements in product compliance. In high-tech industries and specifically in semiconductor related manufacturing, all processes have to be under control. Therefore, CAPA is referred to as OCAP - or Out of Control Action Plan. It describes shop floor level guiding rules to be observed if product non-conformance is detected or excursion (when a process or a tool shifts out of control or specification limits) occurs. Operators, technicians, and engineers will then systematically collect and follow OCAP on re-occurrence typically starting with a root cause analysis.

The Challenges

With the increasing pace of change on the high-tech manufacturing shop floor where product life-times are shrinking, specifically in the semiconductor industry, manufacturing shop floor production execution is becoming more complex every day. By the nature of the processes and their variability, the number of OCAP executed during a day can be substantial. In a manufacturing line, it is common to have 5 to 10 active OCAP at the same time.

For manufacturing management, the challenge is that each OCAP represents a potential short term manufacturing KPI (Key Performance Indicator) degradation. Every OCAP initiated is a potential production lot hold for further investigation creating additional production cycle time variability. It could also inhibit the associated process tool until the equipment is re-qualified. It degrades the overall fab capacity. For overall manufacturing efficiency, the speed of an OCAP execution is crucial. The need to decrease downtime on a specific line or piece of equipment is essential to keep manufacturing capacity high and deliver final product in time to customers.

Seen from a quality perspective, the standard action and root cause identification of OCAP processes are a key factor enabling a higher level of control and fostering continuous improvement. OCAP’s must be executed completely. All analysis need to be performed before equipment is set back to productive and lots are released for production or send to rework.

It is worth mentioning that manufacturing KPIs will improve from OCAP root cause analysis. When rigorously applying OCAP procedures, manufacturing will end up with less unscheduled maintenance and reduced equipment down time. Manufacturing management and quality assurance, both are interested in achieving the same target: better serve the customer with goods that stand out due to a higher quality level. Nevertheless, with respect to OCAP execution, a trade-off is needed between operational performance and quality related interventions. The challenge is to execute OCAP’s faster to preserve manufacturing performance, and more accurately to improve product quality.

By investigating in detail on how OCAP’s typically are managed, you can observe that procedures are defined and manually executed in paper formats, even in high-tech industries which are supposed to deliver leading edge technologies. OCAP’s are typically defined in Excel, PDF, or World documents. Procedures are executed by operators, technicians, and even engineers using simple flat file documents. The execution steps are not always tracked and well documented. This leads to issues when a new shift needs to take over a partially executed OCAP procedure during the change of a shift period. In that case to complete the OCAP, operators need to pass specific context information to the next shift or other certified personnel. This typically is the case when an OCAP is initiated and executed by operators and handed over to a maintenance technician for unscheduled curative equipment maintenance.

OCAP execution tracking: Automotive market driven requirements

Users are asking for OCAP execution tracking and traceability which is usually driven by automotive customers due to ISO & QS certification. Often, an automotive auditor visiting a supplier manufacturing site requests to view OCAP procedures executed and their actual results for a particular excursion. The auditors are typically interested in what are the root cause analysis results, commonality scores, and decision branches physically executed on the shop floor following an OCAP.

Solution requirements

camLine reviewed OCAP processes and best practices with top leading manufacturing companies supplying to automotive and aerospace industry. These activities uncovered the most essential demands in OCAP management solutions. Key fundamental business needs were documented that support both, quality and manufacturing operations aspects. Those can be summarized in few bullets as below:

Ensuring consistence OCAP execution when excursions occur

Automated OCAP step executions

Easy to set up new OCAPs

Capture actions & deviations during OCAP execution

Allowing offline analysis of how effective OCAP executions support the organization in achieving their intended business goals

In audits, providing customers with evidence of stringent OCAP enforcement

Solution approach

Based on these solution requirements, camLine made a full assessment study and outlined a solution of what should be the best OCAP tracking and management approach providing higher user value.

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Conclusions & benefits

For plant level CAPA, operational excellence is driven by an OCAP solution. For high-tech and semiconductors companies, OCAP execution is an integrated part of SPC. The value of LineWorks eCAP increases dramatically when it is used in conjunction with LineWorks SPACE. It extends the SPC power of LineWorks SPACE enabling better control and better product quality, it increases user satisfaction.

LineWorks eCAP benefits for manufacturing operations

Automated execution of OCAP steps drastically reducing OCAP times up to 300%

Reduced tool down time associated to OCAP by a factor of two with automated OCAP steps

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Whitepaper: Successful plant level CAPA deployment (English)

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